Open-Label Single-Arm Phase 2 Study of ALIMTA in Patients With Advanced Non-Small Cell Lung Cancer Who Have Had Prior Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 试验地点
- 21
- 主要终点
- Response rate according to RECIST criteria
研究概览
简要总结
In previous phase 2 studies, pemetrexed has shown antitumor activity in advanced non-small cell lung cancer as a single agent as well as in combination with cisplatin. Since the introduction of vitamin supplementation, pemetrexed has shown good tolerance and high safety. Vitamin supplementation has opened the opportunity to offer patients higher pemetrexed dosing, as has been demonstrated by a recent Phase 1 study. The higher dose with supplementation may increase pemetrexed's efficacy without unduly compromising safety. The present Phase 2 study will use pemetrexed dosing that is tailored to individual patient tolerance, and is an effort to determine the efficacy and safety of this approach in patients with advanced NSCLC who had prior chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of NSCLC
- •Locally advanced or metastatic disease (Stage IIIB or IV).
- •Patients must have previously received one chemotherapy regimen for palliative therapy of locally advanced or metastatic disease.
- •Disease status must be that of measurable disease as defined by RECIST criteria
- •Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Scale; and adequate organ function.
排除标准
- •Known or suspected brain metastasis, or Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
- •Concurrent administration of any other tumor therapy.
- •History of significant neurological or mental disorder, including seizures or dementia; or any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study
- •Inability to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) 2 days before, the day of, and 2 days after the dose of pemetrexed.
- •Inability or unwillingness to take folic acid, vitamin B12 supplementation, or dexamethasone
结局指标
主要结局
Response rate according to RECIST criteria
次要结局
- To assess the following time to event efficacy variables:
- o Duration of overall response for responding patients
- o Time to progressive disease
- o Time to treatment failure
- o Survival
- To characterize the quantitative and qualitative toxicity of pemetrexed when used at tailored dosing in this patient population